Automated Hematology Analyzer
Vietnam·Risk Class TTBYT Loại B·TEK8520·Tecom Science Corporation·Registered Mar 14, 2024- Analysis ID
- 240000543/PCBB-HN
- Submission ID
- 000.00.19.H26-240116-0011
- Product Type
- TEK8520
- Manufacturer
- Tecom Science Corporation
- Product Owner
- Tecom Science Corporation
- Authorized Representative
- CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ TRÍ VIỆT PHÁT
- Intended Use
- The blood test uses a dual-channel system combining impedance, laser scattering, and cell morphology to simultaneously detect white blood cells; it uses a cyanide-free colorimetric method to measure hemoglobin concentration; it uses optical methods to count WBC and BASO; and it uses a multi-angle laser flow cytology technique to obtain a statistical count of five types of white blood cells.
- Registration Date
- Mar 14, 2024
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Access comprehensive regulatory information for Automated Hematology Analyzer in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000543/PCBB-HN and manufactured by Tecom Science Corporation. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ TRÍ VIỆT PHÁT.
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